MAUDE Adverse Event Report: COOK INCORPORATED CAPTURA; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number G32749

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2017

Event Type  malfunction  

Event Description

Three stone extractor baskets malfunctioned during a case.Fourth stone extractor basket had to be opened to finish the case.Per site reporter: manufacturer will initiate a quality control investigation and supply the hospital with replacement product.

• Brand Name: CAPTURA
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6593616
• MDR Text Key: 76038618
• Report Number: 6593616
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017,05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2018
• Device Model Number: G32749
• Device Catalogue Number: CE-532115
• Device Lot Number: 5998934
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR